U.S. top court allows Apotex to pursue generic version of Daiichi drug

The U.S. Supreme Court on Monday rejected appeals by Daiichi Sankyo Inc and Mylan Pharmaceuticals Inc seeking to stop Apotex Inc from trying to introduce a generic version of Benicar, a drug for treating hypertension.Reuters | November 10, 2015, 13:15 IST

The justices declined to review an April ruling by the U.S. Court of Appeals for the Federal Circuit in favor of Apotex.

The appeals court reversed a decision by the U.S. District Court of the Northern District of Illinois, which had dismissed Apotex's lawsuit asking for a declaratory judgment that its generic version of Benicar would not infringe upon one of two patents held by Daiichi, which manufacturers the drug.

Mylan Pharmaceuticals, which wants to introduce a generic version of the drug, sided with Tokyo-based pharmaceutical company Daiichi in the case.

The lower court had tossed out the case on the grounds that there was no controversy because Daiichi had disclaimed the patent in question, so it could not be infringed upon.

Canadian-based generic drug maker Apotex argued that it needed a judgment of non-infringement to win approval from the U.S. Food and Drug Administration to begin selling a generic version, and the appeals court agreed.

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